A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults

Chronic Hepatitis B Clinical Trial

Official title:

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate CYP3A4-Mediated, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04142762
• Other study ID #: ABI-H2158-103
• Status: Completed
• Phase: Phase 1
• Start date: October 18, 2019
• Est. completion date: January 29, 2020

Study information

• Verified date: March 2020
• Source: Assembly Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess 1) the effect of multiple doses of itraconazole (CYP3A4 inhibitor), rifampin (CYP3A4 inducer), and esomeprazole (pH modifier) on the pharmacokinetics of a single oral dose of ABI-H2158, and 2) the effect of steady-state oral ABI-H2158 on the pharmacokinetics of midazolam (sedative) and levonorgestrel/ethinyl estradiol (active oral contraceptive) in healthy adult participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 29, 2020
• Est. primary completion date: January 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.

2. Cohort 5: naive to the use of oral contraceptives.

Exclusion Criteria:

1. Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• ABI-H2158
ABI-H2158 tablets
• Itraconazole
Itraconazole capsules
• Rifampin
Rifampin capsules
• Midazolam
Midazolam syrup
• Ethinyl Estradiol / Levonorgestrel
Ethinyl Estradiol / Levonorgestrel tablets
• Esomeprazole
Esomeprazole capsules
• Placebo matching oral contraceptive
Placebo matching Ethinyl Estradiol / Levonorgestrel tablets

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Assembly Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration time curve (AUC) of ABI-H2158		before dosing and at pre-specified time points up to Day 17
Primary	Maximum observed plasma concentration (Cmax) of ABI-H2158		before dosing and at pre-specified time points up to Day 17
Primary	AUC of Midazolam		before dosing and at pre-specified time points up to Day 12
Primary	Cmax of Midazolam		before dosing and at pre-specified time points up to Day 17
Primary	AUC of ethinyl estradiol and levonorgestrel		before dosing and at pre-specified time points up to 5 days after dosing on Day 21 of Cycle 1 and Cycle 2. Cycle 1 is 28 days and Cycle 2 is 26 days
Primary	Cmax of ethinyl estradiol and levonorgestrel		before dosing and at pre-specified time points up to 5 days after dosing on Day 21 of Cycle 1 and Cycle 2. Cycle 1 is 28 days and Cycle 2 is 26 days